Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol

Terminated

• Conditions: Children, Only; Electroencephalography; Anesthesia
• Interventions: Device: Electroencephalography; Drug: Propofol

• Registration Number: NCT03705338
• Lead Sponsor: Victor Contreras, MSN

Brief Summary

Anesthesia is essential to control pain and produce unconsciousness during surgery and other procedures during childhood. The anesthetic deepness is measured indirectly through changes in blood pressure and heart rate or can be inferred according to estimated or measured concentrations of anesthetics.

In adults, anesthetic dosing, using patterns based on electroencephalogram (EEG) analysis, has shown clinical advantages compared to traditional monitoring. These advantages include lower consumption of hypnotics, less post-operative cognitive deterioration and decreased intraoperative awakening.

The maturation of the brain and Central Nervous System (CNS) that occurs in childhood affects the response of anesthetics. Additionally, the EEG changes with age and its dominant frequency is lower in children. This explains why brain monitoring methods developed in adults do not work well in children. However, these patterns cannot be extrapolated to the pediatric population. Therefore, it is necessary to develop indexes based on EEG with pediatric data to improve the dosage of hypnotics in this population.

The appearance of alpha wave in frontal EEG has been successfully used as a marker of unconsciousness during general anesthesia with GABAergic hypnotics in adults (sevoflurane, propofol). However, in children, the alpha wave appears since 4 months of age in anesthetics with sevoflurane, so studying the characterization of this wave during the loss and recovery of secondary consciousness anesthetic agents such as propofol has not been studied yet.

Detailed Description

Research question:

Is it possible to use the alpha wave as an indicator of loss and recovery of consciousness in anesthesia with propofol in children?

Hypothesis:

The appearance and disappearance of frontal alpha wave is a good indicator of loss and recovery of consciousness in anesthesia with propofol in children.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-15
• Study Start: 2021-03-15
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• ASA I - II
• Indications of phimosis surgery, cryptorchid and/or inguinal hernia surgery

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Exclusion Criteria

• Anatomical limitations for installing the EEG cap.
• Congenital or genetic malformations that influence his/her brain development.
• Neurological or cardiovascular disease
• Use of drugs with effect in the CNS in the last 24 hrs.
• Preterm newborn less than 32 weeks.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electroencephalography	Electroencephalography	Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.
Electroencephalography	Propofol	Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.

Primary Outcome Measures

Name	Time	Method
Loss and Recovery of consciousness	Continuously from start of propofol infusion to unarousable up to ending of infusion arouses without stimuli. In average 2 hrs.	Recorded by the EEG signal - 40 channels waves: Beta, Alpha,Theta
Recovery of consciousness	From to ending of propofol infusion to arouses without stimuli. Continuously for 10 min.	Watching the awakening and/or gross movement. Recorded by Go Pro cam the moment of Recovery of consciousness.
Loss of consciousness	From start of propofol infusion to unarousable to stimuli. Continuously for 10 min.	Level 4 of University of Michigan Sedation Scale for children \[0 0=awake/alert; 1=sleepy/responds appropriately; 2=somnolent/arouses to light stimuli ; 3=deep sleep/arouses to deeper physical stimuli; 4=unarousable to stimuli\]. Recorded by Go Pro cam the moment of loss consciousness.

Secondary Outcome Measures

Name	Time	Method
Arterial Pressure	Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs.	By non invasive Arterial Pressure: Systolic Arterial Pressure in mmHg, diastolic Arterial Pressure in mmHg and Medium Arterial Pressure in mmHg
Saturation Oxigen	Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs.	Pulse Oximetry by reusable sensor in % of saturation.
Heart Rate	Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs.	By EKG D-II bit per minute

Trial Locations

Locations (1)

Victor Contreras; 🇨🇱 Santiago, Región Metropolitana, Chile